Medical Device Contract Manufacturing Market Overview
The Medical Device Contract Manufacturing Market was valued at USD 77.62 billion in 2024. The industry is projected to grow from USD 84.71 billion in 2025 to USD 216.70 billion by 2035, exhibiting a compound annual growth rate (CAGR) of 9.85% during the forecast period (2025 - 2035). The modernization of military fleets and adoption of advanced manufacturing technologies such as additive manufacturing, robotics, and IOT are driving the market growth.
Source: Secondary Research, Primary Research, MRFR Database, and Analyst Review
Medical Device Contract Manufacturing Market Trends
Modernization of military fleets
The expanding aging population and the prevalence of chronic diseases are major factors driving the growth of the Medical Device Contract Manufacturing Market. As the world population ages, there is a growing demand for medical devices that address age-related health concerns. According to the United Nations, the number of individuals aged 65 and older is expected to more than quadruple, from 703 million in 2019 to 1.5 billion by 2050. This demographic transition is fueling the demand for innovative medical devices, including cardiovascular devices, orthopedic implants, and diagnostic equipment, all of which necessitate specific manufacturing capabilities. Chronic diseases, such as diabetes, cardiovascular disease, and respiratory ailments, are growing more common worldwide.
According to the Centers for Disease Control and Prevention (CDC), six out of ten persons in the United States have at least one chronic disease, with four out of ten having two or more. Because of the increasing incidence, a variety of medical equipment for diagnosis, monitoring, and therapy must be developed and manufactured. Contract manufacturers play an important role in satisfying this demand by bringing expertise in making high-quality, dependable medical devices that meet tight regulatory requirements. Furthermore, the complexity of modern medical equipment frequently necessitates sophisticated manufacturing technologies and procedures, which many OEMs find difficult to manage in-house. Contract manufacturers provide specialized services such as design, development, production, and assembly, allowing OEMs to maximize their technical strengths while focusing on innovation and market expansion.
This outsourcing trend is accelerated by contract manufacturers' cost-effectiveness and scalability, which allows OEMs to more easily respond to changing market demands and regional needs. These trends produce a steady demand for innovative medical products, which contract manufacturers can supply thanks to their specialized knowledge and modern manufacturing skills. As healthcare demands grow, contract manufacturers will play an increasingly important role in guaranteeing the availability of high-quality medical products.
Medical Device Contract Manufacturing Market Segment Insights
Global Medical Device Contract Manufacturing Device Type Insight
Based on device type, the Medical Device Contract Manufacturing Market has been bifurcated into IVD Devices, Diagnostic Imaging Devices, Cardiovascular Devices, Drug Delivery Devices, Orthopedic Devices, Respiratory Care Devices, Ophthalmology Devices, Surgical Devices, Diabetes Care Devices, Dental Devices, Endoscopy and Laparoscopy Devices, Gynecology and Urology Devices, Personal Care Devices, Neurology Devices, Patient Monitoring Devices, Patient Assistive Devices, and Other Devices. Drug Delivery Devices accounted for the largest market share in 2025 and IVD Devices segment is projected to grow during the forecast period
The Medical Device Contract Manufacturing Market encompasses a wide array of medical devices, with In Vitro Diagnostic (IVD) devices being essential for disease diagnosis and health monitoring. The increasing prevalence of chronic and infectious diseases, such as diabetes, cardiovascular conditions, and respiratory infections, is a major driver of demand. Other key segments include cardiovascular devices (stents, pacemakers, heart valves), drug delivery devices (insulin pumps, nebulizers, infusion pumps), orthopedic implants, respiratory care devices (ventilators, CPAP machines), ophthalmology tools, surgical instruments, and diabetes care products (CGMs, insulin pens). Additionally, dental equipment, neurology devices, patient monitoring systems, personal care devices, endoscopy and laparoscopy instruments, and patient assistive devices play a significant role in market expansion. Other specialized devices, such as IUDs, implants, biopsy tools, electrophysiological devices, and endodontic instruments, further contribute to the growth of the industry.
Global Medical Device Contract Manufacturing Class Insights
Based on the Class, the Medical Device Contract Manufacturing Market has been bifurcated into Class I Medical Devices, Class II Medical Devices, and Class III Medical Devices. Class II Medical Devices accounted for the largest market share in 2025 and Class III Medical Devices is projected to grow during the forecast period.
Class II medical devices are classified as medium-risk devices, necessitating more regulatory controls than Class I devices but less stringent than Class III. These gadgets are typically utilized in more sophisticated procedures and provide a larger danger if not appropriately regulated. To ensure their safety and efficacy, Class II devices must fulfill particular performance standards and frequently require premarket notification or "510(k) approval" from regulatory agencies such as the United States Food and Drug Administration (FDA). Class II equipment includes infusion pumps, powered wheelchairs, defibrillators, and specific diagnostic imaging systems. Furthermore, the growing emphasis on patient safety and regulatory compliance drives market expansion. Class II devices must meet strict performance standards to assure their safety and dependability. As healthcare systems around the world prioritize high levels of care and safety, the need for compliant Class II devices that fulfill these criteria is likely to increase.
Figure 2: Medical Device Contract Manufacturing Market SIZE, BY CLASS, 2024 & 2035 (USD Billion)
Source: Secondary Research, Primary Research, MRFR Database, and Analyst Review
Global Medical Device Contract Manufacturing Service Insights
Based on the Service, the Medical Device Contract Manufacturing Market has been bifurcated into Device Development and Manufacturing Services, Quality Management Services, Packaging and Assembly Services, and Others. Device Development and Manufacturing Services accounted for the largest market share in 2025 and Quality Management Services is projected to grow during the forecast period.
Device Development and Manufacturing Services comprise all aspects of medical device design, development, and production. These services encompass conceptual design, prototyping, preclinical and clinical testing, regulatory compliance, and full-scale production. Companies that provide these services work closely with medical device manufacturers to develop innovative goods from concept to market-ready solutions, ensuring that devices meet both functional and regulatory standards. This area is critical to the medical device business, providing key assistance throughout the product's life cycle. The rise of personalized medicine and customized devices contributes to the growth of this market sector. With a rising emphasis on adapting medical devices to individual patient demands, there is a greater demand for research and manufacturing services that can handle bespoke solutions.
Quality Management Services in the medical device contract manufacturing sector are a comprehensive strategy to ensure that medical devices fulfill strict quality standards throughout their lifecycle. These services include quality planning, control, assurance, and improvement operations that guarantee devices are safe, effective, and meet regulatory criteria. Quality Management Services encompass responsibilities like developing quality management systems (QMS), performing audits and inspections, keeping paperwork, and executing corrective and preventive measures. These services are critical for maintaining high standards and reducing the hazards involved with medical device manufacturing.
Global Medical Device Contract Manufacturing Regional Insights
Based on the region, the Medical Device Contract Manufacturing Market has been segmented into North America, Europe, Asia-Pacific, South and Rest of the World. North America accounted for the largest market share in 2025.
The North American region is the largest market for worldwide medical device contract manufacturing, thanks to a number of specific elements that contribute to its supremacy. This significance is due to the region's strong healthcare infrastructure, creative technological breakthroughs, and favorable regulatory environment. North America's substantial and well-established healthcare infrastructure is a major contributor to market growth. The United States and Canada have modern healthcare systems with high medical standards and major investments in healthcare technology. This infrastructure serves as a firm foundation for the medical device contract manufacturing business, making it easier to produce and distribute a diverse range of medical equipment. The abundance of healthcare facilities, research institutions, and hospitals produces a significant demand for modern medical gadgets, prompting manufacturers to improve their production capacities and quality standards.
Europe is a substantially greater region in the worldwide medical device contract manufacturing industry, driven by a number of key variables that contribute to its rapid expansion. This growth is mostly driven by the region's robust healthcare system, broad consumer needs, and supportive regulatory environment. The comprehensive and advanced healthcare system in Europe is a major driver of the market. Europe has a well-established network of healthcare facilities and institutions that provide high-quality medical care and make significant investments in healthcare infrastructure. The diversified market needs in Europe also play an important role in the region's medical device contract manufacturing growth. Europe is made up of many different countries, each with its own set of healthcare demands and preferences. This diversity allows contract manufacturers to meet distinct geographical demands and adjust their offerings accordingly.
The Asia Pacific area is the fastest-growing market for worldwide medical device contract manufacturing, thanks to a number of specific elements that contribute to its rapid rise. This expansion is largely due to the region's thriving healthcare industry, increased investments in medical technology, and a dynamic regulatory framework. The Asia Pacific medical device contract manufacturing industry is being driven primarily by the region's rapidly expanding healthcare sector. Countries such as China, India, and Southeast Asia see tremendous economic expansion, which leads to an increase in healthcare expenditure and infrastructure development. This growth includes the construction of new hospitals, diagnostic centers, and research institutions, resulting in increased demand for medical gadgets. The rising availability of healthcare services and access to new medical technologies increases the demand for high-quality, cost-effective manufacturing solutions, which benefits contract manufacturers.
The Rest of the World (RoW) area is witnessing much slower growth in the global medical device contract manufacturing industry than other regions. Despite this slower rate, various distinct causes contribute to the market's growth in these areas, including rising healthcare requirements, emerging markets, and increased investment in healthcare infrastructure. The increased need for healthcare services is one of the key drivers of the RoW region's medical device contract manufacturing market. Many countries in this region are facing growing healthcare demands as a result of demographic shifts, such as aging populations and rising chronic disease rates. As these countries work to improve healthcare access and quality, there is an increased need for innovative medical devices. This increased demand promotes investment in local manufacturing skills as well as collaboration with contract manufacturers that may deliver specific solutions. Emerging markets in the RoW area also play an important role in growing the medical device contract manufacturing sector. Countries in Latin America, the Middle East, and Africa are gradually improving their healthcare systems and becoming more appealing to global medical device companies. As these markets increase, contract manufacturers will have new opportunities to enter and grow in these locations. The growing number of local healthcare facilities and the steady acceptance of innovative medical technologies all contribute to the demand for dependable manufacturing partners.
Figure 3: Medical Device Contract Manufacturing Market BY REGION 2024 & 2035 (USD Billion)
Source: Secondary Research, Primary Research, MRFR Database, and Analyst Review
Global Medical Device Contract Manufacturing Key Market Players & Competitive Insights
The Medical Device Contract Manufacturing Market, with a projected CAGR of 9.68% during the forecast period, is a dynamic and highly competitive sector. Key players such as Jabil and Flex, renowned for their comprehensive solutions covering design, development, and manufacturing, are instrumental in shaping the industry. These companies leverage a wide array of resources and technological expertise to cater to a diverse range of medical devices, including diagnostic and therapeutic devices.
Technological advancements, regulatory compliance, and cost-efficiency are among the primary factors that drive competition. Companies make substantial investments in state-of-the-art technologies such as 3D printing, automation, and robotics to optimize precision and minimize production expenses. However, it's important to note that compliance with rigorous regulatory standards, including those established by the FDA and ISO, is not just a requirement but a commitment to ensuring the highest standards of product safety and market credibility.
Additionally, regional dynamics play a significant role. The market is driven by the high demand for advanced medical technologies and the stringent regulatory requirements in North America and Europe. However, the Asia-Pacific region, particularly India, presents a promising landscape with substantial opportunities due to the expanding healthcare infrastructure and the growing demand for cost-effective solutions. Companies seeking to capitalize on the expanding healthcare requirements and lower manufacturing costs are increasingly turning to this region, signaling a potential for significant growth.
Key Companies in the Medical Device Contract Manufacturing Market include.
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Kimball Electronics (US)
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Gerresheimer AG (Germany)
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West Pharmaceutical Services, Inc. (US)
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Flex Ltd. (US)
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Jabil Inc. (US)
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Sanmina Corporation (US)
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Integer Holding Corporation (US)
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Viant Medical Holding, Inc. (US)
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Nortech Systems Inc. (US)
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Nemera Development SA (France)
Global Medical Device Contract Manufacturing Industry Developments
May 2025: In the United States, Gerresheimer, a global partner and innovative systems and solutions provider for the pharma, biotech, and cosmetics industries, is substantially increasing its production capacities for medical systems, including inhalers and autoinjectors. Gerresheimer is expanding the production area at its Peachtree City site in Georgia, USA, by approximately 18,000 m² (194,000 sqft) throughout two expansion stages. The two new structures are being constructed and equipped at a cost of approximately 166 million euros (USD 180 million) by the company. As part of the expansion, Gerresheimer will generate over 400 new employment opportunities in Peachtree City.
January 2025: Gerresheimer, a manufacturer of pharmaceutical and life sciences products, is investing more than $88 million to expand its operations in Peachtree City, Georgia.
January 2025: Integer acquires contract manufacturer Pulse Technologies for $140 million. The acquisition is anticipated to improve Integer's end-to-end development capabilities.
October 2024: Kimball Electronics, Inc. was the recipient of the 2024 Service Excellence Awards from CIRCUITS ASSEMBLY for obtaining the highest overall customer ratings in four categories: Manufacturing Quality, Technology, Dependability/Timely Delivery, and Value for the Price.
Medical Device Contract Manufacturing Market Segmentation:
Global Medical Device Contract Manufacturing Device Type Outlook
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IVD Device
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IVD Consumables
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IVD Equipments
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Diagnostic Imaging Devices
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Cardiovascular Devices
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Drug Delivery Devices
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Orthopedic Devices
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Respiratory Care Devices
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Ophthalmology Devices
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Surgical Devices
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Diabetes Care Devices
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Dental Devices
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Endoscopy and Laparoscopy Devices
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Gynecology and urology Devices
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Personal Care Devices
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Neurology Devices
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Patient Monitoring Devices
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Patient Assistive Devices
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Other Devices
Global Medical Device Contract Manufacturing Class Outlook
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Class I Medical Device
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Class II Medical Device
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Class III Medical Device
Global Medical Device Contract Manufacturing Class Outlook
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Device Development and Manufacturing Services
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Device and Component Manufacturing
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Process Development Services
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Device Engineering Services
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Quality Management Services
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Packaging and Assembly Services
Global Medical Device Contract Manufacturing Regional Outlook
North America
Europe
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Germany
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France
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UK
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Italy
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Spain
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Rest of Europe
Asia-Pacific
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China
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Japan
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India
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South Korea
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Australia
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Rest of Asia-Pacific
Rest of the World
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Middle East & Africa
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South America
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Report Attribute/Metric
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Details
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Market Size 2024
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USD 77.62 billion
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Market Size 2025
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USD 84.71 billion
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Market Size 2035
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USD 216.70 billion
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Compound Annual Growth Rate (CAGR)
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9.85% (2025-2035)
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Base Year
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2024
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Forecast Period
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2025-2035
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Historical Data
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2019 to 2022
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Forecast Units
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Value (USD Billion)
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Report Coverage
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Revenue Forecast, Market Competitive Landscape, Growth Factors, and Trends.
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Segments Covered
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Device Type, Class, Service, and Region
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Key Companies Profiled
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Kimball Electronics (US), Gerresheimer AG (Germany), West Pharmaceutical Services, Inc. (US), Flex Ltd. (US), Jabil Inc. (US), Sanmina Corporation (US), Integer Holding Corporation (US), Viant Medical Holding, Inc. (US), Nortech Systems Inc. (US), Nemera Development SA (France)
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Key Market Opportunities
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· Increasing demand for customized medical devices
· Rising healthcare needs in emerging markets
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Key Market Dynamics
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· Modernization of military fleets
· Adoption of advanced manufacturing technologies such as additive manufacturing, robotics, and IoT.
· Need for innovative and advanced medical devices .
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Frequently Asked Questions (FAQ) :
The Medical Device Contract Manufacturing Market is anticipated to reach 216.70 billion at a CAGR of 9.85% during the forecast period of 2025-2035.
The Medical Device Contract Manufacturing Market is expected to grow at a 9.85% CAGR during the forecast period from 2025 to 2035.
The North America region market is estimated to hold the largest market share in the Global Medical Device Contract Manufacturing market.
The key players include Kimball Electronics (US), Gerresheimer AG (Germany), West Pharmaceutical Services, Inc. (US), Flex Ltd. (US), Jabil Inc. (US), Sanmina Corporation (US), Integer Holding Corporation (US), Viant Medical Holding, Inc. (US), Nortech Systems Inc. (US), Nemera Development SA (France).
Drug Delivery Devices segment dominated the market in 2024.
